Observational Burden of Illness Study in Patients With Crohn's Disease With and Without Perianal Fistulas in the United States

Jeanne Jiang; Susan E. Cazzetta; Amod Athavale; Maja Kuharic; Tao Fan; Abigail Silber; Vijay Abilash; Nandini Hadker; Emily Sharpe; Pradeep P. Nazarey

doi:10.1016/j.gastha.2023.08.011

Observational Burden of Illness Study in Patients With Crohn's Disease With and Without Perianal Fistulas in the United States

Jeanne Jiang^*, Susan E. Cazzetta, Amod Athavale, Maja Kuharic, Tao Fan, Abigail Silber, Vijay Abilash, Nandini Hadker, Emily Sharpe, Pradeep P. Nazarey

^*Corresponding author for this work

Medical Social Sciences

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

Background and Aims: This study compared disease burden, experiences, and health-related quality of life (HRQoL) between patients with Crohn's perianal fistulas (CPFs) and those with Crohn's disease (CD) without perianal fistulas (PFs; non-PF CD). Methods: This cross-sectional, observational study was conducted in 3 cohorts of US patients aged 18–89 years with self-reported, physician-diagnosed CD: (1) non-PF CD; (2) CPF without PF-related surgery; and (3) CPF with PF-related surgery. Data on medical and surgical interventions, CD-specific symptoms, HRQoL (assessed using the Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaires), and fecal incontinence (assessed using Revised Faecal Incontinence Scale and Fecal Incontinence Quality of Life questionnaires) were collected via a web-enabled questionnaire. Results: In total, 403 patients with CD completed the questionnaire (non-PF CD, n = 300; CPF without surgery, n = 51; CPF with surgery, n = 52). A high symptom burden was seen across cohorts. More patients with CPF underwent ≥1 CD-related surgery and experienced ≥1 failure of CD-related surgery (79% and 20%) vs non-PF CD (53% and 9%; P <.001). Overall HRQoL outcomes were worse for patients with CPF vs non-PF CD, with significantly worse Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaire scores for those without PF-related surgery (P <.01). Across all cohorts, 58% of patients reported experiencing fecal incontinence, which had a greater negative impact (higher Revised Faecal Incontinence Scale scores; lower Fecal Incontinence Quality of Life scores) in patients with CPF vs non-PF CD. Conclusion: Patients with CPF experience substantial HRQoL burden, reflecting the impact of symptoms and medical/surgical interventions. These results may help to inform comprehensive care strategies to improve patient HRQoL.

Original language	English (US)
Pages (from-to)	1066-1076
Number of pages	11
Journal	Gastro Hep Advances
Volume	2
Issue number	8
DOIs	https://doi.org/10.1016/j.gastha.2023.08.011
State	Published - Jan 2023

Funding

Funding: This study was funded by Takeda Pharmaceuticals USA , Inc. The sponsor was involved in the study design and data interpretation. Conflicts of Interest: The authors disclose the following: Jeanne Jiang, Susan E. Cazzetta, Tao Fan, and Pradeep P. Nazarey are employees of Takeda Pharmaceuticals USA, Inc. and receive stock/stock options from Takeda Pharmaceutical Company, Ltd. Amod Athavale, Abigail Silber, and Nandini Hadker are employees of Trinity Life Sciences (contracted by Takeda to conduct this study). Maja Kuharic is employed by the University of Illinois at Chicago and was supported by a Takeda Health Economics and Outcomes Research fellowship at the time of the study. Vijay Abilash and Emily Sharpe were employees of Trinity Life Sciences at the time of the study (contracted by Takeda to conduct this study).

Keywords

Crohn's Perianal Fistulas
Fecal Incontinence
Health-Related Quality of Life
Symptom Burden

ASJC Scopus subject areas

Medicine (miscellaneous)
Gastroenterology
Hepatology

Access to Document

10.1016/j.gastha.2023.08.011

Cite this

@article{59db008e280243dd90eab136771137ed,

title = "Observational Burden of Illness Study in Patients With Crohn's Disease With and Without Perianal Fistulas in the United States",

abstract = "Background and Aims: This study compared disease burden, experiences, and health-related quality of life (HRQoL) between patients with Crohn's perianal fistulas (CPFs) and those with Crohn's disease (CD) without perianal fistulas (PFs; non-PF CD). Methods: This cross-sectional, observational study was conducted in 3 cohorts of US patients aged 18–89 years with self-reported, physician-diagnosed CD: (1) non-PF CD; (2) CPF without PF-related surgery; and (3) CPF with PF-related surgery. Data on medical and surgical interventions, CD-specific symptoms, HRQoL (assessed using the Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaires), and fecal incontinence (assessed using Revised Faecal Incontinence Scale and Fecal Incontinence Quality of Life questionnaires) were collected via a web-enabled questionnaire. Results: In total, 403 patients with CD completed the questionnaire (non-PF CD, n = 300; CPF without surgery, n = 51; CPF with surgery, n = 52). A high symptom burden was seen across cohorts. More patients with CPF underwent ≥1 CD-related surgery and experienced ≥1 failure of CD-related surgery (79\% and 20\%) vs non-PF CD (53\% and 9\%; P <.001). Overall HRQoL outcomes were worse for patients with CPF vs non-PF CD, with significantly worse Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaire scores for those without PF-related surgery (P <.01). Across all cohorts, 58\% of patients reported experiencing fecal incontinence, which had a greater negative impact (higher Revised Faecal Incontinence Scale scores; lower Fecal Incontinence Quality of Life scores) in patients with CPF vs non-PF CD. Conclusion: Patients with CPF experience substantial HRQoL burden, reflecting the impact of symptoms and medical/surgical interventions. These results may help to inform comprehensive care strategies to improve patient HRQoL.",

keywords = "Crohn's Perianal Fistulas, Fecal Incontinence, Health-Related Quality of Life, Symptom Burden",

author = "Jeanne Jiang and Cazzetta, \{Susan E.\} and Amod Athavale and Maja Kuharic and Tao Fan and Abigail Silber and Vijay Abilash and Nandini Hadker and Emily Sharpe and Nazarey, \{Pradeep P.\}",

note = "Publisher Copyright: {\textcopyright} 2023 The Authors",

year = "2023",

month = jan,

doi = "10.1016/j.gastha.2023.08.011",

language = "English (US)",

volume = "2",

pages = "1066--1076",

journal = "Gastro Hep Advances",

issn = "2772-5723",

publisher = "American Gastroenterological Association",

number = "8",

}

TY - JOUR

T1 - Observational Burden of Illness Study in Patients With Crohn's Disease With and Without Perianal Fistulas in the United States

AU - Jiang, Jeanne

AU - Cazzetta, Susan E.

AU - Athavale, Amod

AU - Kuharic, Maja

AU - Fan, Tao

AU - Silber, Abigail

AU - Abilash, Vijay

AU - Hadker, Nandini

AU - Sharpe, Emily

AU - Nazarey, Pradeep P.

PY - 2023/1

Y1 - 2023/1

N2 - Background and Aims: This study compared disease burden, experiences, and health-related quality of life (HRQoL) between patients with Crohn's perianal fistulas (CPFs) and those with Crohn's disease (CD) without perianal fistulas (PFs; non-PF CD). Methods: This cross-sectional, observational study was conducted in 3 cohorts of US patients aged 18–89 years with self-reported, physician-diagnosed CD: (1) non-PF CD; (2) CPF without PF-related surgery; and (3) CPF with PF-related surgery. Data on medical and surgical interventions, CD-specific symptoms, HRQoL (assessed using the Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaires), and fecal incontinence (assessed using Revised Faecal Incontinence Scale and Fecal Incontinence Quality of Life questionnaires) were collected via a web-enabled questionnaire. Results: In total, 403 patients with CD completed the questionnaire (non-PF CD, n = 300; CPF without surgery, n = 51; CPF with surgery, n = 52). A high symptom burden was seen across cohorts. More patients with CPF underwent ≥1 CD-related surgery and experienced ≥1 failure of CD-related surgery (79% and 20%) vs non-PF CD (53% and 9%; P <.001). Overall HRQoL outcomes were worse for patients with CPF vs non-PF CD, with significantly worse Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaire scores for those without PF-related surgery (P <.01). Across all cohorts, 58% of patients reported experiencing fecal incontinence, which had a greater negative impact (higher Revised Faecal Incontinence Scale scores; lower Fecal Incontinence Quality of Life scores) in patients with CPF vs non-PF CD. Conclusion: Patients with CPF experience substantial HRQoL burden, reflecting the impact of symptoms and medical/surgical interventions. These results may help to inform comprehensive care strategies to improve patient HRQoL.

AB - Background and Aims: This study compared disease burden, experiences, and health-related quality of life (HRQoL) between patients with Crohn's perianal fistulas (CPFs) and those with Crohn's disease (CD) without perianal fistulas (PFs; non-PF CD). Methods: This cross-sectional, observational study was conducted in 3 cohorts of US patients aged 18–89 years with self-reported, physician-diagnosed CD: (1) non-PF CD; (2) CPF without PF-related surgery; and (3) CPF with PF-related surgery. Data on medical and surgical interventions, CD-specific symptoms, HRQoL (assessed using the Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaires), and fecal incontinence (assessed using Revised Faecal Incontinence Scale and Fecal Incontinence Quality of Life questionnaires) were collected via a web-enabled questionnaire. Results: In total, 403 patients with CD completed the questionnaire (non-PF CD, n = 300; CPF without surgery, n = 51; CPF with surgery, n = 52). A high symptom burden was seen across cohorts. More patients with CPF underwent ≥1 CD-related surgery and experienced ≥1 failure of CD-related surgery (79% and 20%) vs non-PF CD (53% and 9%; P <.001). Overall HRQoL outcomes were worse for patients with CPF vs non-PF CD, with significantly worse Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaire scores for those without PF-related surgery (P <.01). Across all cohorts, 58% of patients reported experiencing fecal incontinence, which had a greater negative impact (higher Revised Faecal Incontinence Scale scores; lower Fecal Incontinence Quality of Life scores) in patients with CPF vs non-PF CD. Conclusion: Patients with CPF experience substantial HRQoL burden, reflecting the impact of symptoms and medical/surgical interventions. These results may help to inform comprehensive care strategies to improve patient HRQoL.

KW - Crohn's Perianal Fistulas

KW - Fecal Incontinence

KW - Health-Related Quality of Life

KW - Symptom Burden

UR - https://www.scopus.com/pages/publications/85176097045

UR - https://www.scopus.com/inward/citedby.url?scp=85176097045&partnerID=8YFLogxK

U2 - 10.1016/j.gastha.2023.08.011

DO - 10.1016/j.gastha.2023.08.011

M3 - Article

C2 - 39131564

AN - SCOPUS:85176097045

SN - 2772-5723

VL - 2

SP - 1066

EP - 1076

JO - Gastro Hep Advances

JF - Gastro Hep Advances

IS - 8

ER -

Observational Burden of Illness Study in Patients With Crohn's Disease With and Without Perianal Fistulas in the United States

Abstract

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this